抗肿瘤药物临床试验中不良事件规范化判断的探讨
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摘要
抗肿瘤药物的临床试验一般选择肿瘤患者作为受试者。由于肿瘤患者通常伴有复杂的全身疾病状态,对研究者准确判断临床试验期间不良事件造成困扰。本文从研究医生的角度出发,探讨通过参与试验方案的设计,全员培训统一的不良事件判断规则,以及采取多学科协作的方式,对抗肿瘤药物临床试验中的不良事件进行规范化判断,从而提高抗肿瘤药物临床试验的质量。
The clinical trials of anti-tumor drugs generally select tumor patients as subjects. Due to the complexity of systemic disease status of tumor patients,it is difficult for investigators to accurately judge the adverse events during the clinical trials. This article from the perspective of the study doctor, discuss how to conduct standardized judgment of adverse events in anti-tumor drugs clinical trials,by participating in design the protocol of clinical trials,implementing employee training to unify the rules of judgment of the adverse events and using a multiple disciplinary team approach,in order to improve the quality of clinical trials of anti-tumor drugs.
The clinical trials of anti-tumor drugs generally select tumor patients as subjects. Due to the complexity of systemic disease status of tumor patients,it is difficult for investigators to accurately judge the adverse events during the clinical trials. This article from the perspective of the study doctor, discuss how to conduct standardized judgment of adverse events in anti-tumor drugs clinical trials,by participating in design the protocol of clinical trials,implementing employee training to unify the rules of judgment of the adverse events and using a multiple disciplinary team approach,in order to improve the quality of clinical trials of anti-tumor drugs.
引文
[1]张雷,郝纯毅,廖红舞,等.抗肿瘤药物临床试验的特点和医学伦理问题[J].肿瘤防治研究,2017,44(7):506-508.
[2]赵淑华,江旻.抗肿瘤药物临床试验质量控制体系的建立[J].中国新药杂志,2014,23(13):1546-1548.
[3]国家食品药品监督管理局.药物临床试验质量管理规范[EB/OL].北京:国家食品药品监督管理局. 2003-08-06[2018-09-30]. http://cnda. cfda. gov. cn/WS04/CL2077/300595. html.
[4]孙燕.抗肿瘤新药的临床试验[J].中国医师杂志,2001(6):408-411.
[5]顾俊,李娜,张志勇.浅议药物临床试验机构的风险管理[J].中国新药与临床杂志,2011,30(10):797-800.
[6]ARJUN LAKSHMAN,MANISH MODI,GAURAV PRAKASH,et al. Evaluation of bortezomib-induced neuropathy using total neuropathy score(reduced and clinical versions)and NCI CTCAE v4. 0 in newly diagnosed patients with multiple myeloma receiving bortezomib-based induction[J]. Clin Lymphoma Myeloma Leuk,2017,17(8):513-519.
[7]张伟杰,常志伟,王留兴.多学科综合治疗在恶性肿瘤治疗及临床教学中的重要性[J].肿瘤基础与临床,2016,29(3):268-270.
[8]雷翔,郑文科,王辉,等浅谈临床试验中不良事件记录欠佳的原因和改善方法[J].中国新药杂志,2014,23(11):1260-1263.
[9]郭韶洁,赵秀丽,周辉.临床试验中不良事件管理的问题及分析[J].中国临床药理学杂志,2014,30(1):73-74,77.
[10]丁惠萍.抗肿瘤药物的血液系统毒性及防治[J].医药导报,2001(10):622-623.
[2]赵淑华,江旻.抗肿瘤药物临床试验质量控制体系的建立[J].中国新药杂志,2014,23(13):1546-1548.
[3]国家食品药品监督管理局.药物临床试验质量管理规范[EB/OL].北京:国家食品药品监督管理局. 2003-08-06[2018-09-30]. http://cnda. cfda. gov. cn/WS04/CL2077/300595. html.
[4]孙燕.抗肿瘤新药的临床试验[J].中国医师杂志,2001(6):408-411.
[5]顾俊,李娜,张志勇.浅议药物临床试验机构的风险管理[J].中国新药与临床杂志,2011,30(10):797-800.
[6]ARJUN LAKSHMAN,MANISH MODI,GAURAV PRAKASH,et al. Evaluation of bortezomib-induced neuropathy using total neuropathy score(reduced and clinical versions)and NCI CTCAE v4. 0 in newly diagnosed patients with multiple myeloma receiving bortezomib-based induction[J]. Clin Lymphoma Myeloma Leuk,2017,17(8):513-519.
[7]张伟杰,常志伟,王留兴.多学科综合治疗在恶性肿瘤治疗及临床教学中的重要性[J].肿瘤基础与临床,2016,29(3):268-270.
[8]雷翔,郑文科,王辉,等浅谈临床试验中不良事件记录欠佳的原因和改善方法[J].中国新药杂志,2014,23(11):1260-1263.
[9]郭韶洁,赵秀丽,周辉.临床试验中不良事件管理的问题及分析[J].中国临床药理学杂志,2014,30(1):73-74,77.
[10]丁惠萍.抗肿瘤药物的血液系统毒性及防治[J].医药导报,2001(10):622-623.